Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Pregabalin: Pregabalin starting at 75 mg orally daily, with dose escalation over 7 days (according to dose escalation schedule)to a maximum dose of 300 mg orally daily for 9 weeks follo
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 years or older. 2.Locally advanced or metastatic suspected or diagnosed NSCLC. 3.Eastern Cooperative Group performance status between 0 and 2. 4.Moderate (grade 2) or severe (grade 3) cough that has lasted for 2 or more weeks. Cough severity will be according to the Common Terminology Criteria for Adverse Events (CTCAE), v.5, in which grade 2 signifies moderate symptoms, medical intervention required, limiting instrumental activities of daily living; and grade 3 cough signifies severe symptoms limiting self-care activities of daily living. 5.Willing and able to limit to one alcoholic beverage per day (e.g. 360 ml of beer or 120 ml of wine or 330 ml of cooler or 43 ml of hard liquor like whisky/ vodka/ rum/ gin). 6.Creatinine clearance measured by the Cockcroft-Gault formula > 60 ml/min. 7.Women of childbearing potential must be willing to consent to using effective contraception (e.g.,hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. A man who is the partner of a woman of childbearing potential must be willing to consent to using effective contraception (e.g., vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter. 8.Capable of providing informed consent and follow trial procedures.
Exclusion criteria
Exclusion criteria: 1.Patients already receiving pregabalin or gabapentin, irrespective of indication, at the time of screening. 2.Known hypersensitivity to pregabalin or gabapentin or their components. 3.Pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of Pregabalin[max dose 300mg] on cough severity as measured by the Visual Analog Scale(VAS)Timepoint: Between Baseline & 9 Weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the effect of Pregabalin[max dose 300mg] on cough severity as measured by the Manchester Cough in Lung Cancer Scale (MCLCS) score 2.Change in VAS and MCLCS scores between baseline and day 7 of therapy with pregabalin(maximal tolerable dose of 300 mg per day) as compared to matching placebo. 3.Quality of Life 4.Adverse effects of pregabalinTimepoint: 1.Between Baseline & 9 Weeks of treatment 2.Basline & day7 in both arms 3.Baseline & Day 7 & At 9 weeks (End of Treatment) 4.Each visit | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Hospital, Parel, Mumbai
Outcome results
None listed